Adeza's NDA for Gestiva to prevent preterm birth recommended by FDA committee

B y Lisa Kerner

Charlotte, N.C., Aug. 30 - The Reproductive Health Drugs Advisory Committee to the Food and Drug Administration recommended that the data presented by Adeza in its New Drug Application for Gestiva support efficacy in preventing preterm birth prior to 35 weeks.

In addition, the overall safety data is sufficient to support marketing approval in women with a history of preterm delivery.

"With approximately one preterm birth every minute and a $26 billion annual cost to the U.S. health care system, preterm birth is a major public health issue," president and chief executive officer Emory V. Anderson said in a company news release.

"Treating women with a history of preterm birth with Gestiva could considerably reduce preterm birth and the associated costs for this high risk group."

Gestiva is a long-acting form of a naturally occurring progesterone.

Located in Sunnyvale, Calif., Adeza manufactures and markets products for women's health.

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